Minystag MN-1
FDA 510(k) K780338 · Lkb Instruments, Inc.
510(k) numberK780338
Submission
- Device name
- Minystag MN-1
- Applicant
- Lkb Instruments, Inc.
Mchenry, IL, US - Received
- March 1, 1978
- Decision date
- March 15, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSF – Recorder, Paper Chart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2810
- Specialty
- Cardiovascular
Other 510(k)s with product code DSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | Edentec Corp. | 08/29/1991SE |
| K912929 | Dash IVDSF · Traditional | Astro-Med, Inc. | 08/13/1991SE |
| K905856 | Model 556 MonitorDSF · Traditional | Ge Medical Systems Information Technologies | 01/11/1991SE |
| K902586 | Gri Lasergraph(Tm) ECG PaperDSF · Traditional | Gri Medical Products, Inc. | 06/22/1990SE |
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | Honeywell, Inc. | 06/19/1990SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | Gabriel Medical, Inc. | 05/09/1990SE |
| K895111 | Type 9541 Recorder, Paper ChartDSF · Traditional | S & W Medico Teknik | 01/26/1990SE |
| K894922 | WR3500 and WR3600 Series RecordersDSF · Traditional | Western Graphtec | 01/26/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | Astro-Med, Inc. | 12/13/1989SE |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
More from Protocol Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | 11/04/1987SE |
| K872955 | Delfia(Tm) Ferritin KitJMG · Traditional | 08/21/1987SE |
| K871303 | Delfia(Tm) Thyroxine (T4) KitCDX · Traditional | 06/17/1987SE |
| K871599 | Delfia(Tm) Hige KitDHB · Traditional | 06/12/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | 05/12/1987SE |
| K864452 | Delfia(Tm) Triiodothyronine (T3) KitCDP · Traditional | 02/02/1987SE |
| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
| K863422 | Delfia(Tm) Cortisol KitJFT · Traditional | 09/26/1986SE |
| K862044 | Delfia (TM) HCG KitJHJ · Traditional | 07/11/1986SE |
Questions and answers
When was Minystag MN-1 cleared by the FDA?
Minystag MN-1 (K780338) received a 510(k) decision of Substantially Equivalent on March 15, 1978, 14 days after the submission was received.
What is the product code of K780338?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.